NCT06539676

A Study to Compare Nighttime Aligners to Daytime Aligners

A Prospective, Two-armed, Multicenter Clinical Study to Evaluate Efficacy, Performance, and Safety of Nighttime Aligners (Worn 10-12 Hours Day or Night) Compared to Daytime Aligners (Worn 20-22 Hours Day/Night)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Dentsply Sirona Implants and Consumables · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to see if Nighttime Aligners (worn 10-12 hours per day or night) are effective and safe for tooth movement and if so, how they compare with the standard Daytime aligners (worn 20-22 hours per day), in adults and children from 12 years of age and older. It will investigate the efficacy and performance of the treatments, as well as the safety of the investigational device and comparator. The main objectives are: * Comparison between the two groups concerning actual vs planned tooth movements (measured by changes in tooth position) * Comparison between the two groups concerning the incidence of device or dental related AEs. * Overall dentist and participant satisfaction with the treatment. Participants will: * Be given orthodontic aligner therapy with the Daytime (20-22h/day) or Nighttime (10-12h/day) Aligners (randomly assigned) * Attend approximately 5 study during approximately 8-10 months

Conditions

• Teeth Straightening
• Aligner Therapy
• Orthodontic Aligner

Interventions

Type	Name	Description
DEVICE	Nighttime Aligners	Nighttime aligners worn 10-12 hours per day or night during 2-8 months
DEVICE	Daytime Aligners	Daytime aligners worn 20-22 hours per day or night during 2-8 months

Timeline

• Start date: 2024-09-04
• Primary completion: 2025-01-17
• Completion: 2025-01-17
• First posted: 2024-08-06
• Last updated: 2025-07-16
• Results posted: 2025-07-16

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated device study